Finalization of Facility Documents

ICWI0084.02 Page 1 of 4

Author: Sharon Mundt

Issue Date: 03Jul18

Source Document: ICSOP0018, Processing Facility Documents

This document is to give direction to the Biologics Compliance Assistant (BCA) to 

finalize facility documents and the additional documents that the Specialist has provided. 

(NOTE: The work instruction that the Specialists use is ICWI0083, Facility Documents: 

Specialist Review and Outgoing Correspondence.)

I. Hard Copy Submissions

The Specialist will return all facility documents and hard copy of the FDS form signed 

(not dated) back to the BCA. The BCA can re-verify that all facility documents are as 

stated on the FDS form and the boxes have been checked.

A. Documents Filed

1. Date stamp the FDS form the same date as the facility documents are stamped

2. Ensure the Specialist has marked the correct box on the FDS form in Block 9, 

CVB Action, as Documents Filed

3. Verify the Specialist signed the FDS form

4. Date stamp the facility documents that have been approved by the Specialist with 

the USDA stamp in bottom right-hand corner of document

5. Scan the signed and dated FDS form and attach as Outgoing General 

Correspondence

6. Make a copy of FDS form for CVB files

7. Add Notifications

8. When all documents have been attached and the Submission Response has been 

filled out, ensure tag for Suppress Response From Portal has been done

9. Move Mail Log item to the Specialist as Sign Correspondence (IC)

10. Give the purple folder to the Specialist to “sign” and move onto Section Leader

B. Documents Filed, Revisions Requested

1. Date stamp the FDS form the same date as the facility documents are stamped

2. Ensure the Specialist has marked the correct box on the FDS form in Block 9, 

CVB Action, as Documents Filed, Revisions Requested

3. Verify the Specialist signed the FDS form

4. Date stamp the facility documents that have been approved by the Specialist with 

the USDA stamp

5. Scan the signed and dated FDS form and attach as Outgoing General 

Correspondence

6. Make a copy of FDS form for CVB files

7. Add Notifications

8. Finalize the ICTEM0045, Facility Documents Filed – Revisions Requested (no 

legend line is needed on this document, just the ML#) 

9. Pdf the document and attach as Outgoing Enclosures
Finalization of Facility Documents

ICWI0084.02 Page 2 of 4

Author: Sharon Mundt

Issue Date: 03Jul18

Source Document: ICSOP0018, Processing Facility Documents

10. When all documents have been attached and the Submission Response has been 

filled out, ensure tag for Suppress Response From Portal has been done

11. Move Mail Log item to the Specialist as Sign Correspondence (IC)

12. Give the purple folder to the Specialist to “sign” and move onto Section Leader

C. Documents Returned

1. Date stamp the FDS form the same date as the facility documents are returned

2. Ensure the Specialist has marked the correct box on the FDS form in Block 9, 

CVB Action, as Documents Returned

3. Verify the Specialist signed the FDS form

4. Scan the signed and dated FDS form and attach as Outgoing General 

Correspondence

5. Make a copy of FDS form for CVB files

6. Add Notifications

7. Finalize the ICTEM0045, Facility Documents Returned - Resubmit with 

Corrections by [date] (no legend line is needed on this document, just the ML#)

8. Pdf the document and attach as Outgoing Enclosures
Finalization of Facility Documents

ICWI0084.02 Page 3 of 4

Author: Sharon Mundt

Issue Date: 03Jul18

Source Document: ICSOP0018, Processing Facility Documents

9. When all documents have been attached and the Submission Response has been 

filled out, ensure tag for Suppress Response from Portal has been done

10. Move Mail Log item to the Specialist as Sign Correspondence (IC)

11. Give the purple folder to the Specialist to “sign” and move onto Section Leader.

NOTE – only one ICTEM0045 is required per ML submission. It may have both 

Revisions Requested and Documents Returned. 

Facility documents and additional documents will be returned to the firm as Certified 

Mail. The Section Leader should return the Mail Log to the BCA as Certified Receipt.

II. Electronic Submissions

A. Documents Filed

1. No “Outgoing General Corr” is needed 

2. Open the IC Clean Copy type for each document 

3. Ensure the appropriate stamp is applied 
Finalization of Facility Documents

ICWI0084.02 Page 4 of 4

Author: Sharon Mundt

Issue Date: 03Jul18

Source Document: ICSOP0018, Processing Facility Documents

4. Ensure there is a DATE under the stamp. It should be close to the date of Review 

(Specialist)

5. Review nomenclature for each document – see ICWI0083, Section V and VII.C

6. If correct, upload all documents as “Outgoing Enclosure” (Do not upload any 

Summary of Changes)

7. Add Notifications

8. Complete Submission Response under Info tab

9. Move Mail Log item to the Specialist as Sign Correspondence (IC)

B. Documents Filed, Revisions Requested

1. Finalize ICTEM0049 for the Specialist’s digital signature 

2. Attach pdf copy of ICTEM0049 as “Outgoing General Corr”

3. Open the IC Clean Copy type for each document 

4. Ensure the appropriate stamp is applied 

5. Ensure there is a DATE under the stamp. It should be close to the date of Review 

(Specialist)

6. Review nomenclature for each document – see ICWI0083, Section V and VII.C

7. If correct, upload all documents as “Outgoing Enclosure” (Do not upload any 

Summary of Changes)

8. Add Notifications

9. Complete Submission Response under Info tab

10. Move Mail Log item to the Specialist as Sign Correspondence (IC)

C. Documents Returned

1. Finalize ICTEM0049 for the Specialist’s digital signature 

2. Attach pdf copy of ICTEM0049 as “Outgoing General Corr” 

3. Ensure there are no outgoing enclosures

4. Add Notifications

5. Complete Submission Response under Info tab

6. Move Mail Log item to the Specialist as Sign Correspondence (IC)

NOTE – Under the Documents tab, there should only be the incoming attachment(s), a 

Clean Copy for each document filed, and outgoing enclosure(s) and/or 1 outgoing 

correspondence.